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Trial Title:
EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer
NCT ID:
NCT06011772
Condition:
Colo-rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Bevacizumab
Cetuximab
Panitumumab
Oxaliplatin
Fluorouracil
Irinotecan
Vaccines
Monatide (IMS 3015)
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Description:
Given IM
Arm group label:
Cohort A1
Arm group label:
Cohort A2
Arm group label:
Cohort B1
Arm group label:
Cohort B2
Arm group label:
Cohort C
Other name:
Cimavax
Other name:
CIMAvax EGF
Other name:
Epidermal Growth Factor (EGF) Vaccine
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Given IV
Arm group label:
Cohort A1
Arm group label:
Cohort A2
Arm group label:
Cohort B1
Arm group label:
Cohort C
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Given IV
Arm group label:
Cohort A1
Arm group label:
Cohort A2
Arm group label:
Cohort B2
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Given IV
Arm group label:
Cohort A1
Arm group label:
Cohort A2
Arm group label:
Cohort B1
Arm group label:
Cohort B2
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
Given IV
Arm group label:
Cohort A1
Arm group label:
Cohort C
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Given IV
Arm group label:
Cohort B1
Intervention type:
Biological
Intervention name:
Cetuximab
Description:
Given IV
Arm group label:
Cohort B1
Arm group label:
Cohort B2
Arm group label:
Cohort C
Intervention type:
Procedure
Intervention name:
Metastasectomy
Description:
Undergo metastasectomy
Arm group label:
Cohort C
Intervention type:
Procedure
Intervention name:
Biospecimen collection
Description:
Undergo collection of blood samples
Arm group label:
Cohort B1
Arm group label:
Cohort B2
Arm group label:
Cohort C
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Cohort A1
Arm group label:
Cohort A2
Other name:
CAT
Other name:
CAT SCAN
Intervention type:
Biological
Intervention name:
Panitumumbab
Description:
Given IV
Arm group label:
Cohort A2
Other name:
ABX-EGF
Other name:
ABX-EGF Monoclonal Antibody
Summary:
The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine
(that is, its effectiveness in inducing an anti-tumor immune response) in patients with
metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination
with standard therapies used in the treatment of advanced colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic adenocarcinoma of colon or
rectum that cannot be removed by surgery without prior systemic therapy for advanced
disease (prior adjuvant chemotherapy completed >12 months from diagnosis of
metastatic or advanced disease is allowed) for cohorts A and C and with one prior
line of therapy but no more than 2 prior lines of therapy for advanced disease
(prior adjuvant chemotherapy completed <12 months from diagnosis of metastatic or
advanced disease is considered one line of therapy).
- Cohort A: May have received 1 cycle of mFOLFOX6± Bevacizumab or mFOLFOX6±
anti-EGFR therapy pending results of RAS and BRAF. If results determine patient
is eligible, the patient will be enrolled and will receive the addition of
CIMAvax + Bevacizumab or CIMAvax+ anti-EGFR therapy in their second cycle.
- Cohort B: Patients with RAS- and BRAF wild-type metastatic CRC who have
received at least one but no more than 2 prior therapies for advanced disease
- Cohort C: Patients with RAS- and BRAF wild-type metastatic CRC who have not
received prior therapy for advanced disease and are candidates for liver
metastasectomy (one cycle of standard therapy with mFOLFOX6 with or without
appropriate biologic agent is allowed)
- KRAS/NRAS/BRAF wild-type.
- Have an ECOG Performance Status of 0 1. Refer to Appendix A.
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 8 g/dL
- Creatinine clearance> 60 mL/min (Cockcroft-Gault Equation)
- ALT and AST ≤ 3 x ULN (ALT and AST ≤ 5 x ULN is acceptable if liver metastases
are present
- Total bilirubin ≤ 1.5x ULN. For patients with well documented Gilbert's
syndrome, total bilirubin ≤ 3x ULN with direct bilirubin within normal range
- Have measurable disease per RECIST 1.1 criteria present.
- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) prior to
study entry. Should a woman become pregnant or suspect she is pregnant while she or
her partner is participating in this study, she should inform her treating physician
immediately.
- Participant must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure.
- Participant agrees to provide tumor biopsy tissue while on study (cohort A and B) or
allow tissue to be taken during surgery (cohort C)
Exclusion Criteria:
- Toxicity ≥Grade 2 from prior chemotherapy.
- Other cancer requiring active treatment.
- Prior exposure to anti-EGFR monoclonal antibody (i.e. cetuximab or panitumumab) for
colorectal cancer treatment.
- Had major surgery within 4 weeks prior to starting study drug or has not recovered
from major side effects (tumor biopsy is not considered major surgery) resulting
from a prior surgery.
- Has known immunosuppressive disease (e.g. HIV, AIDS or other immune depressing
disease). Testing is not mandatory.
- Participants with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive
neurologic dysfunction that would confound the evaluation of neurologic and other
adverse events.
- Active, clinically serious infections or other serious uncontrolled medical
conditions or psychiatric illness/social situations that would limit compliance with
study requirements.
- History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the patient's
participation for the full duration of the study, or is not in the best interest of
the patient to participate, in the opinion of the treating Investigator, including,
but not limited to:
- Myocardial infarction or arterial thromboembolic events within 6 months prior
to baseline or severe or unstable angina, New York Heart Association (NYHA)
Class III or IV disease
- History of documented congestive heart failure (New York Heart Association
functional classification III or IV) within 6 months prior to baseline
- Uncontrolled hypertension (SBP>160/DBP>100 despite medical intervention).
- History of myocarditis of any etiology
- History of ventricular arrhythmias
- Active major or clinically significant bleeding based on the International Society
on Thrombosis and Hemostasis definition.
- Pregnant or nursing female participants.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Start date:
December 4, 2023
Completion date:
December 4, 2026
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011772
